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The Polso™ Watch is a wrist-worn device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2), pulse rate, and respiration rate. The Polso™ Watch is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions.

The device is not intended to be used for diagnostic applications nor is it intended to independently guide treatment decisions. The device is not an apnea monitor. Physiological parameters will later be provided for remote review by a clinician.

The Polso™ Watch is a wearable device intended for non-invasive measurements and display of pulse rate (PR), blood oxygen saturation (SpO2), and respiration rate (RR). It is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor it is intended to independently guide treatment decisions.

The Polso™ Watch is worn on the wrist and features sensors that are located facing the radial artery and at the dorsal wrist, for measurement of physiological information. The Polso™ Watch screen displays measurements, battery status, Bluetooth connection status, and time of day. The Control Button allows navigation between different display screens. The Polso™ Watch is available in sizes S, M and L to cover wrist sizes from 5.5″ to 8.4″ circumference. The Polso™ Watch is powered by a rechargeable lithium-polymer battery.

The Polso™ Watch is paired with a companion mobile application (Polso™ App) on an Android device. The App is used to set up the Polso™ Watch and to review up to 3 months of measurement data.

The information provided primarily describes the Polso™ Watch, a pulse oximeter device, and its regulatory clearance. While it details what was tested (SpO2, Pulse Rate, Respiration Rate accuracy) and how (against gold standards, following ISO standards), it does not explicitly present specific numerical acceptance criteria for these accuracy metrics, nor does it provide the exact reported device performance values in a table as requested. Instead, it states the Polso™ Watch's accuracy for SpO2, Pulse Rate, and Respiration Rate in the comparison table with predicate devices.

Here's an attempt to address your request based on the available information, with clear indications where specific numerical data for acceptance criteria and reported performance is not explicitly detailed in the provided text.

Acceptance Criteria and Device Performance Study for Polso™ Watch

The Polso™ Watch underwent non-clinical and clinical testing to demonstrate its safety and performance and to establish substantial equivalence to predicate devices. The key performance metrics studied were SpO2 accuracy, Pulse Rate accuracy, and Respiration Rate accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for the accuracy tests (e.g., "Must achieve SpO2 accuracy of X% ARMS"). Instead, it compares the Polso™ Watch's stated accuracy to that of its predicate devices. We can infer the "acceptance" is based on demonstrating performance comparable to or better than the predicate, within recognized industry standards (ISO 80601-2-61).

Note on RR Accuracy and Display Range Units: The document consistently uses "BPM" (beats per minute) for Respiration Rate (RR) accuracy and display range of the Polso™ Watch, while using "RPM" (respirations per minute) for predicate devices. Assuming this is a clerical error and BPM is intended to mean respirations per minute in this context, the values are directly comparable.

2. Sample Size and Data Provenance

• SpO2 and Pulse Rate Validation Study:
  • Sample Size: 10 healthy adult subjects initially, with data on two additional subjects provided later, making a total of 12 subjects (for Fitzpatrick scores IV and VI).
  • Data Provenance: Not explicitly stated (e.g., specific country), but typical for a medical device regulatory submission, it would likely be from a controlled clinical trial setting. The studies were prospective as they were conducted to validate the device's performance.
• Respiration Rate Validation Study:
  • Sample Size: 31 adult subjects.
  • Data Provenance: Not explicitly stated. The study was prospective.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "manual, clinician-scored End Tidal Carbon Dioxide monitoring" and "arterial blood samples assessed by SaO2 CO-Oximetry" as gold standards. It does not specify the number or specific qualifications of the clinicians/experts involved in establishing these "manual" or "clinician-scored" ground truths.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the ground truth establishment in either of the clinical studies. The "gold standard" methods (arterial blood samples, manual clinician-scored ETCO2) inherently serve as the adjudicated truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how human readers/clinicians improve with AI vs. without AI assistance. The device is a measurement device (oximeter), not an AI-powered diagnostic imaging tool that typically involves MRMC studies for human reader performance.

6. Standalone (Algorithm Only) Performance

The "Reported Device Performance" listed in the table effectively represents the standalone performance of the Polso™ Watch (i.e., the algorithm/device output accuracy) without human-in-the-loop assistance for the core measurement functions.

7. Type of Ground Truth Used

• For SpO2 and Pulse Rate: Arterial blood samples assessed by SaO2 CO-Oximetry (this is an objective, physiological measurement and considered a "gold standard").
• For Respiration Rate: Manual, clinician-scored End Tidal Carbon Dioxide (ETCO2) monitoring. This relies on expert observation/scoring of physiological data.

8. Sample Size for the Training Set

The document does not provide details on the training set sample size. It only discusses the clinical validation/test sets. As a measurement device (oximeter) based on photoplethysmography, its core algorithms are likely based on established physiological principles and signal processing, rather than deep learning that requires distinct, large training sets in the same way an imaging AI algorithm would. If machine learning was used in some aspect of signal processing, the training data would be internal and not specified here.

9. How Ground Truth for Training Set Was Established

Not applicable/not provided, as per item 8. The document focuses on the validation studies against established "gold standards," not the internal development/training process.

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